| CTRI Number |
CTRI/2013/03/003486 [Registered on: 15/03/2013] Trial Registered Prospectively |
| Last Modified On: |
13/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effect of taping on quadriceps strength in patients with osteoarthritis |
|
Scientific Title of Study
|
Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 26101987 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASudarshan |
| Designation |
post graduate student |
| Affiliation |
Coventry university |
| Address |
Department of physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054
Bangalore KARNATAKA 560054 India |
| Phone |
|
| Fax |
|
| Email |
anandkumar.sudarshan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs SHOBHALAKSHMI |
| Designation |
Assistant professor |
| Affiliation |
Coventry university |
| Address |
Department of physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054
Bangalore KARNATAKA 560054 India |
| Phone |
9008025432 |
| Fax |
|
| Email |
msrmcpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mrs SHOBHALAKSHMI |
| Designation |
Assistant professor |
| Affiliation |
Coventry university |
| Address |
Department of physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054
Bangalore KARNATAKA 560054 India |
| Phone |
9008025432 |
| Fax |
|
| Email |
msrmcpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah medical teaching hospital |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah hospitals |
| Address |
Department of Physiotherapy, MS Ramaiah medical college, MSRIT post, MSR nagar, Bangalore - 560054 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ASudarshan |
Out-patient departments of Orthopaedics and Physiotherapy - M.S Ramaiah Hospitals |
MS Ramaiah hospitals, MSRIT post, MSR nagar, Bangalore - 560054 Bangalore KARNATAKA |
8431131061
anandkumar.sudarshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah medical college and hospitals ethical review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Knee osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Kinesio taping |
For the control group receiving sham taping, the directions of the tape application with the three “I†strips are the same as the experimental group. However, no stretch will be applied in the tape and the knee will not be flexed for the paper off application. That is, the tape will be stuck as such on the knee with no activation of the glue. |
| Intervention |
Therapeutic Kinesio taping |
For therapeutic KT application, three “I†strips were taken and applied. The base of the first strip was applied 10 cm below the anterior superior iliac spine. Following this, the tape was pulled with a 50% - 75% tension along the course of the rectus femoris until the superior border of the patella. The knee was then flexed to 45 degrees with the remaining strip applied in a paper-off tension (without tension) extending over the superior border of the patella. The base of the second “I†strip was applied below the greater trochanter and the tape was pulled with a 50% - 75% tension along the course of the vastus lateralis until the lateral border of the patella. Following this, the knee was flexed to 45 degrees and the remaining strip was applied with a paper-off tension (without tension) around the lateral border of patella towards the tibial tuberosity. The base of the third strip was applied from the middle 1/3rd of the medial aspect of the thigh. The tape was pulled with a 50% to 75% tension along the course of vastus medialis towards the medial border of the patella. Following this, the knee was flexed to 45 degrees and the remaining strip was applied with a paper off tension (without tension) around the medial border of patella ending towards the tibial tuberosity. After application of the tape, they were rubbed upon with paper to activate the glue. The tape will be removed immediately after measuring the primary and secondary outcome measures. The tape will be applied only once. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group – 40 to 65 years
2. Sex- Both males and females
3. Diagnosis according to American College of Rheumatology criteria
4. Radiographic severity according to the K-L scale ≤ grade 2
|
|
| ExclusionCriteria |
| Details |
1. Clinical evidence of Varus / Valgus malalignment
2. Neurological deficits
3. Subjects who are undergoing any physiotherapy treatment for the current knee pain
4. Infectious / systemic arthritis of the knee
5. Any pathology preventing isokinetic testing (eg. Lumbar nerve root compression, myopathy).
6. Language / cognitive deficits that might limit the informed consent
7. Current or past (within 4 weeks) use of oral corticosteroid
8. Knee surgery or intra-articular corticosteroid injection within the past 6 months
9. Knee instability or sensation of knee “giving outâ€
10. Unable to ambulate without gait aid
11. Presence of other disorders affecting the lower limbs (such as plantar fascitis)
12. History of treatment with Kinesio tape application
13. History of any skin allergy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| peak quadriceps torque (measured using an isokinetic dynamometer) concentric and eccentric contraction at angular velocities of 90 degrees per second and 120 degrees per second |
Pre taping and immediate post taping |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Standardised stair climbing task (SSCT) and visual analogue scale (VAS) |
Pre taping and immediate post taping |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rationale: The knee joint
is commonly affected in osteoarthritis where the strength of the quadriceps
muscle and its torque producing capability is frequently found to be
compromised. Recently, the use of kinesio taping as an intervention in
musculoskeletal disorders has become popular amongst physiotherapists. However,
its ability to improve the isokinetic knee performance has conflicting results
in literature with only few studies showing an increase in the quadriceps
torque. This warrants further investigation in knee osteoarthritis, forming the
basis for this study. Objective: To compare the isokinetic
quadriceps torque, standardized stair-climbing task and pain between subjects
in experimental and control group before and after kinesio tape application. Materials
and method: A double blind pre-test post-test control group design will
be followed where 40 subjects will be randomly allocated to either the
experimental or control group. Subjects
will be recruited from the out-patient departments of orthopaedics and
physiotherapy-MS Ramaiah Hospitals using random sampling. The dependent
variables for this study are peak
quadriceps torque (measured using an isokinetic dynamometer), standardized
stair-climbing task (where the time taken to ascend and descend 5 stairs “as
quickly and as safely†as possible would be noted) and pain (measured using the
visual analogue scale). A pre test measurement of the variables will be carried
out by a blinded assessor following which the kinesio tape application will be
done by the principal investigator. The blinded assessor will then carry out
the post test measurement of the same variables. Statistical method: Descriptive
statistics will be used to compare the baseline characteristics of the
experimental and the control group (utilizing mean and standard deviation). Student t test (unpaired) will be used
to compare the peak quadriceps torque values and the time taken in the
standardized stair climbing task between the experimental and control group. The
Student t test (paired) will be used to analyze the within group variations for
the same. Mann-whitney U test will be used to compare the pain scores of VAS
between the experimental and control group with the Wilcoxon signed-rank test used
to compare the within group variations.
|